UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050648 |
|---|---|
| Receipt number | R000057318 |
| Scientific Title | Assessment of oxytocin concentration during the treatment of chronic pain |
| Date of disclosure of the study information | 2023/03/22 |
| Last modified on | 2023/09/21 18:35:28 |
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Basic information
Public title
Assessment of oxytocin concentration during the treatment of chronic pain
Acronym
Assessment of oxytocin concentration during the treatment of chronic pain
Scientific Title
Assessment of oxytocin concentration during the treatment of chronic pain
Scientific Title:Acronym
Assessment of oxytocin concentration during the treatment of chronic pain
Region
| Japan |
Condition
Condition
Diseases that may progress to chronic pain, such as post-stroke central pain or herpes zoster infection
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to find out how oxytocin contributes to pain relief. Pain assessment scales in each treatment phase is being investigated. As a control group, samples from healthy volunteers before and after music therapy will be collected to determine whether the changes are due to treatment. Moreover, norepinephrine, cortisol, and alpha amylases are also measured quantitatively in each phase according to the course of treatment, such as before the start of treatment, after music therapy and before the treatment, and after the oral drug treatment or peripheral nerve block treatment for chronic pain patients who visited the pain clinic in Tohoku university hospital.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to find out how oxytocin contributes to pain relief. Pain assessment scales in each treatment phase is being investigated. As a control group, samples from healthy volunteers before and after music therapy will be collected to determine whether the changes are due to treatment. Moreover, norepinephrine, cortisol, and alpha amylases are also measured quantitatively in each phase according to the course of treatment, such as before the start of treatment, after music therapy and before the treatment, and after the oral drug treatment or peripheral nerve block treatment for chronic pain patients who visited the pain clinic in Tohoku university hospital.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Measure the fluctuation of salivary oxytocin concentration at each phase, such as before the start of treatment, after music therapy, and after pain relief was obtained by various treatments such as oral medication and peripheral nerve block.
Key secondary outcomes
Compare the concentrations of catecholamines such as noradrenaline and cortisol, alpha amylase, and the pain rating scale in each treatment phase with the above-mentioned oxytocin concentration. As a control group, samples from healthy volunteers before and after music therapy will also be collected to determine whether the changes are due to treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We measure salivary and urinary concentrations of oxytocin and norepinephrine after music therapy before the start of treatment for patients who visited our hospital's pain clinic outpatient with chronic pain or a disease that may transit to chronic pain.
Interventions/Control_2
As a control group for Intervention 1, music therapy will be administered to healthy volunteers in the same way, and the same concentration will be measured and compared.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who visit the Tohoku University Hospital Pain Clinic Center with chief complaints of chronic pain associated with post-stroke central pain and herpes zoster.
Key exclusion criteria
Substance abuse patients, entry refusal
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Department of Operation
Zip code
980-8575
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7321
Homepage URL
hidehisa.saito.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Masanori Yamauchi
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057318
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